July 2, 2012
ELITech Molecular Diagnostics receives FDA clearance for commercial Real-Time PCR MRSA/SA test.
ELITech Molecular Diagnostics received FDA clearance for its MRSA/SA ELITe MGB® test, a new multiplex, qualitative Real-Time PCR assay for the direct detection of Staphylococcus aureus (SA) and methicillin-resistant Staphylococcus aureus (MRSA) DNA purified from human nasal swab specimens. MRSA/SA ELITe MGB® was designed to more accurately detect MRSA infections; generating from 27 % – 50 % fewer missed MRSA infections when compared to published values of competing amplification methods, and 3 times fewer missed MRSA when compared to culture.1,2
The assay’s multiplex design combines proprietary MGB Technology and unique biomarkers that target conserved regions of a Staphylococcus aureus-specific gene (patent applied for) and the mecA gene. The combination of unique gene targets and MGB Technology further enables accurate detection by avoiding primer/probe sequence mismatches due to mecA, SSCmec junction and spa gene heterogeneity inherent in other Real-Time PCR assays.
Current MRSA detection methods suffer from unacceptably high levels of false negative and false positive results.1,2 False negative and false positive MRSA and S. aureus results present serious medical and economic challenges for healthcare providers impacting patient outcomes, staff safety and overall costs. Each missed MRSA infection may result in additional costs of $15,000 to $35,000 per patient.2 The unique design of MRSA/SA ELITe MGB® confers outstanding detection performance with fewer false negative and false positive MRSA results, enabling healthcare providers to make better medical decisions, improve patient outcomes and deliver a superior level of service and patient care.
In a statement by Pierre Debiais, President and CEO of the ELITech Group “We are very pleased to introduce this newest molecular diagnostic test that addresses a critical unmet need for clinicians and healthcare providers. MRSA/SA ELITe MGB® utilizes a unique biomarker design for improved accuracy that results in fewer MRSA false negative and false positive results. The unique design of ELITech’s MRSA/SA ELITe MGB®, with our exclusive MGB Technology provides an important new tool that will help clinicians effectively detect MRSA/SA and aid in the prevention and control of MRSA infections. MRSA/SA ELITe MGB® is the first 510(k) cleared molecular diagnostics test from ELITech, and will soon be followed by C. difficile ELITe MGB® currently pending FDA clearance.”
- Clinical data values for this analysis excerpted from the ‘’Expected Results’’ section of each manufacturers’ package insert.
- Based on results published and summarized in “The impact of incorrect MRSA diagnoses”, MLO, January 2012, pp 26-27.
About ELITech Molecular Diagnostics
ELITech Molecular Diagnostics (formerly NAD and EPOCH Biosciences) has established its position as a leading PCR innovator with our MGB Technology and over 45 years of industry experieince. With more than 50 molecular products available, all ELITe MGB® Real-Time PCR products are developed with ELITech Molecular Diagnostics’ patented MGB® Technology (Minor Groove Binder). The MGB moiety binds to the minor groove of double stranded DNA molecules which stabilizes DNA heteroduplexes. The specificity of shorter DNA probes is well established in the scientific literature and the stability conferred by the MGB moiety allows the assay to be designed with short and highly specific DNA probes. MGB DNA probes are more likely to detect DNA mismatches thereby enabling excellent discrimination of sequence variants.
About the ELITech Group
The ELITech Group is a privately held group of worldwide manufacturers and distributors of in vitro diagnostic equipment and reagents. By bringing together IVD specialty companies that offer innovative products and solutions, ELITech Group has become a major contributor in advancing clinical diagnostics to laboratories in the proximity market, those operating closer to the patient. The ELITech Group manufactures and distributes diagnostic products for clinical chemistry, microbiology, immunology, and molecular biology though direct sales and a distribution network encompassing more than 100 countries. For more information about MRSA/SA ELITe MGB® contact David DeBonville, Product Manager at ELITech North America 609-216-7365 or visit: www.elitechgroup.com/north-america/home
MRSA/SA ELITe MGB® is FDA cleared for use on the bioMerieux nucliSENS easyMAG® and ABI 7500 Fast Dx® instruments. nucliSENS easyMAG® is a registered trademark of bioMerieux, Inc. ABI 7500 Fast Dx® is a registered trademark of Applied BioSystems, Inc.